Waiting For Completion Of All Clinical Trial Stages

KOMPAS/RONY ARIYANTO NUGROHO

A man received a vaccine injection during a series of simulations to administer the anti-Covid 19 vaccine at the Tapos Puskesmas, Tapos District, Depok City, West Java, Thursday (22/10/2020).

JAKARTA, KOMPAS – Frontline workers, who were to be the first to be vaccinated, have refused to receive any Covid-19 vaccine before all stages of clinical trials have been completed and the result published in scientific journals. The safety and efficacy of the vaccines are nonnegotiable.

In response to the issue, Wiku Adisasmito, who chairs the expert team of the Covid-19 Mitigation Task Force, emphasized that the government guaranteed the safety and effectiveness of the Covid-19 vaccine to be provided. A vaccine would be administered only if it had passed all stages of the clinical trials.

Also read: Public Communication on Vaccines Need Improvement

"The vaccines that will be provided to the public must pass all stages of the clinical trials, so they are safe and effective to use," said Wiku.

Separately, professor Ari Fahrial Syam, who is also the dean of the University of Indonesia medical school, said, "Professional [medical] organizations will refuse if a Covid-19 vaccine is administered before it has completed the clinical trials. As a doctor, I [also] refuse, because a vaccine must be based on evidence and scientific principles. Their safety and efficacy must be [proven]."

The vaccines that will be provided to the public must pass all stages of the clinical trials, so they are safe and effective to use

In connection with this matter, he called on the government to wait for candidate vaccines to complete all clinical trial stages and be evaluated. Apart from safety, a potential vaccine must also have high efficacy.

The reasons behind emergency use authorization (EUA) could not be justified for Indonesia.

"We cannot imitate China in using the EUA. The cases there were brought under control through of testing, tracing and isolating, not through vaccination,” Ari said.

Also read: Self-Reliance on Covid-19 Vaccine

AP PHOTO/NG HAN GUAN

An employee manually inspects syringes of the SARS CoV-2 Vaccine for COVID-19 produced by SinoVac at its factory in Beijing on Thursday, Sept. 24, 2020. A Chinese health official said Friday, Sept. 25,2020, that the country\'s annual production capacity for coronavirus vaccines will top 1 billion doses next year, following an aggressive government support program for construction of new factories.

Covid-19 transmission could be currently reduced by implementing the health protocols.

"For health workers, just provide a complete set of personal protective equipment and supplements, as well as a comfortable work environment," said Ari.

Furthermore, the government must involve experts and academics in formulating strategies for public vaccination programs.

Also read: Acceptance, the Key to Vaccination

"The considerations must be scientific, in accordance with the health principles, and cannot be simply political or economic," he said.

Deputy chairman Adib Khumaidi of the Indonesian Medical Association (IDI) said the organization had sent a letter to the Health Ministry to be careful when selecting the Covid-19 vaccines. According to President Joko Widodo\'s instruction, there was no need to rush mass vaccination.

The letter signed by IDI chairman Daeng M. Faqih states that the effectiveness, immunogenicity (immune response to a pathogen) and safety must be proven for the vaccine intended for distribution and administration. These are verified in the third phase of the vaccine’s clinical trials.

Also read: Acceptance, the Key to Vaccination

Guaranteeing safety

Wiku said that the government guaranteed the safety and effectiveness of the Covid-19 vaccine that would be provided for public use. A vaccine would be provided only if it had passed all stages of the clinical trials.

Vaccine development begins with basic research to identify the pathogen (virus) and the infected cells. Then, a preclinical trial is conducted by applying the candidate vaccine to infected cells, and then it is tested on lab animals. If the candidate vaccine successfully and safely completes the preclinical trial, it then undergoes a three-phase clinical trial. When the candidate vaccine has completed the third phase of the clinical trials with satisfactory results, it is then submitted to the Food and Drug Monitoring Agency (BPOM) for evaluation and approval. Once it has BPOM approval, the vaccine can enter mass production.

Also read: The Race to Creating a Vaccine

AFP/WANG ZHAO

Sinovac Biotech vaccines, one of 11 Chinese companies approved to carry out clinical trials of potential coronavirus vaccines, are displayed at a press conference during a media tour of a new factory built to produce Covid-19 coronavirus vaccines, in Beijing on September 24, 2020.

To date, no country has commenced mass production of a Covid-19 vaccine. The Indonesian government is making efforts to procure both domestic and foreign vaccines. Several pharmaceutical manufacturers are working together to produce vaccines, such as Sinovac, Sinopharm, Cansino, Astrazeneca, and Genexine.

"Vaccine development must be done carefully, but responsively to dynamic changes during the pandemic," said Wiku.

A vaccine will be first administered to priority recipient groups, namely workers on the Covid-19 frontlines and people at high risk of infection. After this, the vaccine will be administered to other citizens, under the target to vaccinate 60-80 percent of the population by the end of 2021.

Also read : One More Step to Take for Vaccine

According to Wiku, the government was still identifying the priority recipient groups that would receive free and mandatory vaccination. Decisions were still being finalized regarding the priority areas for vaccine distribution. Wiku therefore asked that local administrations do not make unilateral announcements.

Generally, said Wiku, the government was trying its best to achieve equitable vaccine distribution and thus achieve community immunity.